title: A multi-institutional phase II trial of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis.
abstract: OBJECTIVE
  The objective of this study was to evaluate the response rate, survival, and adverse effects of hepatic arterial infusion chemotherapy (HAIC) using cisplatin in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT).
  
  
  METHODS
  Twenty-five patients of advanced HCC with PVTT in the main or first branch, having no prior history of chemotherapy, measurable lesions, adequate liver and renal function, and adequate bone marrow reserve, were enrolled. Cisplatin was administered at the dose of 65 mg/m(2) via the proper hepatic artery. Treatment was repeated every 4-6 weeks for a maximum of six courses until the appearance of evidence of tumor progression or unacceptable toxicity.
  
  
  RESULTS
  The median number of treatments was 3 (range 1-6). Among the 25 enrolled patients, complete response was achieved in 1 (4 %) patient and partial response in 6 (24 %), corresponding to a response rate of 28 % (95 % CI 12-49 %). The median progression-free and overall survival times and the 1-, 2-, and 3-year survival rates in the enrolled patients were 3.6 and 7.6 months and 40.3, 36.0, 20 %, respectively. Four of the seven patients who showed complete or partial response survived for more than 3 years. The main grade 3/4 non-hematological adverse events of this treatment were elevation of the serum aspartate aminotransferase (44 %) and alanine aminotransferase (24 %).
  
  
  CONCLUSIONS
  HAIC with cisplatin exerts moderate activity with mild toxicity in advanced HCC patients with PVTT. Especially, markedly prolonged survival can be expected in patients who respond to this treatment.
authors.affiliation: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan. masikeda@east.ncc.go.jp
authors.forename: Masafumi
authors.initials: M
authors.lastname: Ikeda
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
authors.forename: Junji
authors.initials: J
authors.lastname: Furuse
authors.forename: Shuichi
authors.initials: S
authors.lastname: Mitsunaga
authors.forename: Hideki
authors.initials: H
authors.lastname: Ueno
authors.forename: Hidekazu
authors.initials: H
authors.lastname: Yamaura
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Inaba
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Satake
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Arai
mesh_terms: D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D001780:Blood Coagulation Tests; D006528:Carcinoma, Hepatocellular / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D008113:Liver Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011169:Portal Vein; D016019:Survival Analysis; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000150:complications*
chemical_list: D000970:Antineoplastic Agents; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D002945:Cisplatin